Center for Research on Complex Generics (U18) Clinical Trials Optional
Forecasted Federal grant Posted
- Opportunity number
- FOR-FD-25-004
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications expected due
- Not on record
- Award size
- $1,500,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Consumer Protection
- Agriculture
- Food and Nutrition
- Eligible applicants
-
- Unrestricted
- State Governments
- Independent School Districts
- Higher Education Inst. (Private)
- City/Township Governments
- 501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- County Governments
- Small Businesses
- Special District Governments
- For Profit Organizations
- Tribal Governments (Federally Recognized)
- Points of contact
-
- Terrin Brown terrin.brown@fda.hhs.gov (240) 402-7610
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is soliciting applications for a Center for Research on Complex Generics cooperative agreement to enhance collaboration with the generic drug industry on generic drug research and development. Applicant eligibility is unrestricted; State Governments, Higher Education Institutions (public and private), County and City/Township Governments, 501(c)(3 and non-501(c)(3) Nonprofits, Tribal Organizations (federally recognized and not federally recognized), Small Businesses, For Profit Organizations, and other entity types may apply.
The Center will function as a coordination hub between the FDA and generic drug industry stakeholders—including academic experts, industry associations, and companies—to identify scientific challenges in generic product development and research priorities. Core activities include facilitating industry engagement to inform FDA research priorities; convening expert collaborations on generic drug research; coordinating and conducting research projects focused on complex generics; hosting scientific workshops and training; and providing public access to generic drug research outputs including scientific articles, posters, and presentations.
The funding instrument is a cooperative agreement, indicating FDA involvement in programmatic oversight and collaboration. The program operates under CFDA 93.103 (Food and Drug Administration Research), which has sustained activity over 45 years with recent awards ranging from $50 thousand to $6.8 million and an annual award rate of 90 to 167 grants. Cooperative Agreements comprise 58 percent of awards under this CFDA.
No explicit cost share requirement, award ceiling, or period of performance is stated in the source material.
Forecast synopsis
The Food and Drug Administration (FDA) seeks to fund a Center for Research on Complex Generics under the terms and conditions of a cooperative agreement. The Center for Research on Complex Generics will support the FDA's efforts to enhance collaborations with the generic drug industry relating to generic drug research, to further the FDA's mission of increasing patient access to high quality, safe, and effective generic drugs.
The goals of a Center for Research on Complex Generics include:
1) Facilitating engagement with generic industry representatives to help identify scientific challenges for generic product development or assessment, and helping to inform FDA about priority areas for research to address these challenges by supporting engagement and coordination between the FDA and key generic industry industry associations, companies, and representatives.
2) Providing a forum for experts from FDA, academia, the generic drug industry, and elsewhere to collaborate on research related to generic products.
3) Coordinating and conducting research projects pertaining to generic products, particularly complex generics.
4) Hosting scientific workshops, providing training, and supporting other educational activities pertaining to generic drug research.
5) Providing free and open public access to generic drug research outcomes such as scientific articles, posters, presentations, and other resources that help the generic drug industry to leverage scientific insights from FDA funded generic drug research.
The Center for Research on Complex Generics is expected to complement FDA's existing regulatory science programs through its specific focus as a hub for coordination and engagement between FDA and the public, including academic experts, generic industry representatives, and other stakeholders.
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